Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China

Completed

• Conditions: Invasive Group B Streptococcal Disease

• Registration Number: NCT01933646
• Lead Sponsor: Novartis Vaccines

Brief Summary

Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-28
• Study Start: 2013-09
• Study First Posted: 2013-09-02
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Positive culture for GBS from one or more of the following normally sterile sites: blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain).
2. ≤90 days old at the time of GBS confirmation.
3. Voluntary written informed consent provided.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of group B streptococcal (GBS) disease	From birth to 90 days of age
GBS serotype distribution	From birth to 90 days of age
Case Fatality Rate of GBS disease	From birth to 90 days of age

Trial Locations

Locations (3)

Site 12; 🇨🇳 Changsha, China

Site 13; 🇨🇳 Guangzhou, China

Site 14; 🇨🇳 Guangzhou, China